Ganoderma Spores Modulate the Gut-Brain Axis

August 25, 2026 updated by: Ling Zhiqiang

Targeting the Gut-Brain Axis With Ganoderma Lucidum Spores Ameliorates Depression in Thyroid Cancer Patients: a Randomized, Double-blind, Placebo-controlled Trial

This study aims to investigate whether Sporoderm-removed Ganoderma lucidum spore powder (RGLS) ameliorates depression in thyroid cancer patients through gut-brain axis modulation, and to elucidate the underlying microbial and metabolic mechanisms. This 3-month randomized, double-blind, placebo-controlled trial will enroll 300 postoperative papillary thyroid carcinoma patients with depressive symptoms (HAMD-24 ≥ 8). Participants will be randomly assigned(2 : 1) to receive RGLS (4 g/day) or matched placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Outpatients at Zhejiang Cancer Hospital with histologically confirmed papillary thyroid carcinoma (post-surgery) and depressive symptoms (HAMD-24 score ≥ 8, confirmed by a clinical psychologist).
  • Han Chinese ethnicity.
  • No history of depression or other psychiatric disorders.
  • Age 18-80 years.
  • Female.

Exclusion Criteria:

  • Suffering from other gastrointestinal system diseases.
  • History of gastrointestinal surgery prior to intervention.
  • Including those with other concurrent malignancies requiring chemotherapy, radiotherapy, biological therapy, or traditional Chinese medicine treatment.
  • Received antibiotic treatment or microecological modulators within 3 months prior to intervention.
  • Acute intestinal obstruction.
  • Patients who are currently taking antidepressant medication, or those whom the investigators judge require immediate initiation of antidepressant medication treatment.
  • Organic brain diseases, brain trauma.
  • History of psychiatric disorders, use of psychoactive substances (e.g., drugs).
  • Severe liver or kidney dysfunction.
  • Pregnancy or lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo group
Other: Placebo
From the first day after enrollment, subjects take placebo orally at 4g/day for 3 months.
Experimental: Sporoderm-removed Ganoderma lucidum spore powder (RGLS)
Dietary supplement: Sporoderm-removed Ganoderma lucidum spore powder (RGLS)
From the first day after enrollment, subjects take RGLS orally at 4g/day for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Hamilton Depression Rating Scale-24（HAMD-24）score from baseline to 3 months of RGLS intervention
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline to 3 months of RGLS intervention.
Time Frame: 3 months
3 months
Changes in gut microbial species from baseline to 3 months of RGLS intervention.
Time Frame: 3 months
3 months
Change in serum metabolites from baseline to 3 months of RGLS intervention.
Time Frame: 3 months
3 months

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events in both groups, including patient-reported symptoms and laboratory parameters.
Time Frame: 3 months
3 months
Changes in thyroid function parameters from baseline to 3 months in the RGLS and placebo groups
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ling Zhiqiang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2026

Primary Completion (Actual)

July 31, 2026

Study Completion (Actual)

July 31, 2026

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2026-288（IIT）

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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